Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: VENTAK PRIZM AVT AICD SYSTEM
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S028
• Date Received: 08/05/2002
• Decision Date: 03/27/2003
• Product Codes: KRG LWP
• Docket Number: 05M-0435
• Notice Date: 10/31/2005
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE VANTAK PRIZM AVT AICD SYSTEM. THE DEVICE IS INDICATED FOR USE IN THE FOLLOWING: PATIENTS WHO ARE ICD INDICATED AND WHO HAVE ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. PATIENT POPULATIONS WHO ARE INDICATED FOR A GUIDANT ICD INCLUDE: 1) THOSE WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS, OR 2) PATIENTS WHO MAY BENEFIT FROM PROPHYLACTIC TREATMENT DUE TO A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION <=30% (AS DEFINED IN THE MADIT II CLINICAL STUDY APPENDIX).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling